Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, NIDEK, has issued a medical device safety alert concerning its Preloaded versions of SZ-1 and SZ-1C [All Lots] [HKMD No.: 160147].
The manufacturer is informing users that while it undergoes a full investigation due to a limited number of reports of high ocular hypertension in patients who were implanted with one of these lenses. A preliminary investigation has thus far not established a link between these affected products and the reports of high ocular hypertension or identified a root cause.
The manufacturer is continuing to investigation this issue to definitively determine the root cause and will provide an update on its investigation. Affected users should stop using and quarantine the affected products until further notice.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Mar 2023